M13-596 2nd gen HCV treatment in transplant subjects
Research type
Research Study
Full title
A Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of ABT-493/ABT-530 in Adult Post-Liver or Post-Renal Transplant Subjects with Chronic Hepatitis C Virus Genotype 1 – 6 Infection (MAGELLAN-2)
IRAS ID
200786
Contact name
David Mutimer
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co.KG
Eudract number
2015-005616-14
Duration of Study in the UK
1 years, 3 months, 10 days
Research summary
Hepatitis C infection is among the most common of all chronic liver disease worldwide and it is a leading cause of liver transplant in the UK. A liver transplant does not usually cure the infection, and the new liver can also become damaged by the Hepatitis C virus. Until recently, with the emergence of DAAs, treatment options for hepatitis C treatment have been limited.
AbbVie is currently developing two "next generation" DAAs, ABT-493 and ABT-530. This study will test the drugs in combination to check that they are safe and effective for patients with Hepatitis C who have received a liver or kidney transplant. Subjects who have Hepatitis C and have either never had treatment or have taken medications to treat Hepatitis C and they were not effective could be eligible to take part in this study.
Approximately 70 subjects will be included across approximately 30 sites worldwide. The study will be conducted in three hospitals in the UK. Subjects will attend regular study visits at clinics during the course of the study. Participation in this study will last approximately 42 weeks. Subjects will receive study medication for 12 weeks then follow up for 24 weeks. The effect of the treatments on the virus will be checked by performing blood tests and collecting general medical health information. Safety and efficacy evaluations will occur throughout the study.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0128
Date of REC Opinion
31 May 2016
REC opinion
Further Information Favourable Opinion